AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

Phase 3

Not yet recruiting

• Conditions: Triple-Negative Breast Cancer (TNBC)
• Interventions: Drug: AK112; Drug: Nab-paclitaxel; Drug: Placebo

• Registration Number: NCT06767527
• Lead Sponsor: Akeso

Brief Summary

This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

1. Voluntarily sign a written informed consent form.
2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
6. Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
7. Suitable for monotherapy with taxane-based agents.
8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
9. Adequate organ function.

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Exclusion Criteria

1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
2. History of other malignancies within the past 5 years.
3. Active autoimmune disease requiring systemic treatment within the past 2 years.
4. Pregnant or breastfeeding women.
5. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
7. Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
8. Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK112	AK112	AK112 Plus Nab-Paclitaxel
AK112	Nab-paclitaxel	AK112 Plus Nab-Paclitaxel
Placebo	Nab-paclitaxel	Placebo Plus Nab-Paclitaxel
Placebo	Placebo	Placebo Plus Nab-Paclitaxel

Primary Outcome Measures

Name	Time	Method
PFS assessed by IRRC	Up to approximately 2 years	Progression-Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC)
OS	Up to approximately 4 years	Overall survival (OS) is defined as the time from randomization to death due to any cause

Secondary Outcome Measures

Name	Time	Method
PFS assessed by investigator	Up to approximately 2 years	Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first.
ORR assessed by IRRC or investigators	Up to approximately 2 years	Objective Response Rate (ORR) is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by IRRC or investigators based on RECIST 1.1 is presented.
DCR assessed by IRRC or investigators	Up to approximately 2 years	Disease control rate (DCR) is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by IRRC or investigators using RECIST v1.1
DoR assessed by IRRC or investigators	Up to approximately 2 years	Duration of response (DoR) is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.
TTR assessed by IRRC or investigators	Up to approximately 2 years	Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Adverse Events (AEs)	Up to approximately 2 years	Incidence and severity of participants with adverse events
Cmax and Cmin	Up to approximately 2 years	AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Anti-drug antibodies (ADA)	Up to approximately 2 years	Number of subjects with detectable anti-drug antibodies (ADA).

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China